1. Field of the Invention
In some embodiments this invention relates to a package assembly suitable for use with environmentally sensitive products, and more particularly for use with one or more medical devices.
2. Description of the Related Art
Packages suitable for use with environmentally sensitive products such as medical devices employ various configurations and/or mechanisms to provide the package interior, and the medical device contained therein, with a secure and sterile storage environment. Modern medical devices however, often employ a drug component that can complicate the packaging solution by requiring more than just a sterile environment.
From providing moisture control, to physical protection, the addition of a drug component, such as a coating, upon a medical device to be packaged requires more dynamic packaging solutions than those presently available.
Some examples of known packaging solutions that are directed to medical devices include:
U.S. Pat. No. 5,577,368 to Hamilton et al. and U.S. Pat. No. 6,174,934 to Sun et al. The packages and packaging procedures described in these references seek to remove the oxygen/atmosphere from the packaging prior to radiation sterilization of medical implants made of polymeric material in order to reduce the wear resistance of the polymeric implant.
U.S. Pat. No. 4,941,308 to Grabenkort et al. discloses sterilizing the interior of a package before placing the product in an inner package, sterilizing the product in the inner package, and then placing the inner package into an outer package. Grabenkort et al. uses ethylene oxide gas (EtO) for the sterilization.
U.S. Pat. No. 7,040,485 to Gupta and U.S. Publication 2007/0084144 A1 to Labrecque et al. describe pouches that employ gas permeable headers intended to allow transfer of gasses between the pouch interior and the header before and during sterilization. These headers extend out from the pouch and may be optionally removed.
Despite the availability of such packaging solutions, there remains a need for an efficient packaging assembly and method suitable for use with particularly specialized products such as medical devices, and particularly medical devices having a drug coating or similar therapeutic component.
The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists.
All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.